Drug Uses

Flextra DS is an analgesic and antipyretic used to treat pain, headache, and fever. Flextra DS may also be used to relieve pain in certain kinds of arthritic conditions. Flextra DS is also used to treat other conditions as determined by your doctor.

How Taken

Take this medicine by mouth usually every 4 hours as needed or as directed by your doctor. The dosage is based on your age, medical condition, and response to therapy. Do not exceed the recommended dosage or take this medicine for longer than recommended (e.g., 10 days for adults, 5 days for children, or 3 days if used for fever); persistent symptoms of pain or fever may be the sign of a more serious medical condition. Consult your doctor for additional information.

Warnings/Precautions

Tell your doctor your medical history, especially of: lung problems (e.g., bronchitis, emphysema), glaucoma, enlarged prostate or any allergies. This medicine may make you dizzy or drowsy; use caution engaging in activities requiring alertness such as driving or using machinery. Limit alcoholic beverages. Flextra DS may cause liver damage. Daily use of alcohol and Flextra DS may increase your risk for liver damage (symptoms include nausea, stomach pain, dark urine). Check with your doctor or pharmacist for more information. Caution is advised when using this product in children because they may be more sensitive to the effects of the drug (e.g., increased excitability). Tell your doctor if you are pregnant before using this medicine. It is unknown if this drug passes into breast milk. Consult your doctor before breast-feeding.

Missed Dose

Take the missed dose of Flextra DS prescription muscle relaxer as soon as you remember. However, if it is almost time for your next dose of Flextra DS prescription muscle relaxer, skip the missed dose and take only your next regularly scheduled dose. Do not take a double dose of Flextra DS prescription muscle relaxer.

Possible Side Effects

Drowsiness or nausea may occur. If either of these effects persist or worsen, notify your doctor promptly. Tell your doctor immediately if any of these unlikely but serious side effects occur: skin redness, swelling, persistent fever, stomach pain, yellowing eyes and skin, dark urine, unusual weakness. If you notice other effects not listed above, contact your doctor or pharmacist.

Storage

Store at room temperature between 59 and 86 degrees F (15 and 30 degrees C) away from light and moisture.

Overdose

The following symptoms indicate an overdose, get medical help immediately: difficulty breathing, extreme nervousness or restlessness, flushed skin, hallucination, racing or irregular heartbeat, seizure, shortness of breath, tiredness (extreme), unstable temperature, unusual muscle stiffness, vomiting (in combination with these other symptoms).

More Information

DO NOT DRIVE, OPERATE MACHINERY OR DO ANYTHING ELSE THAT COULD BE DANGEROUS until you know how you react to this medicine. Using this medicine alone, with other medicines, or with alcohol may lessen your ability to drive or to perform other potentially dangerous tasks. Do not take additional acetaminophen for pain or fever without checking with your doctor or pharmacist. Ask your pharmacist if you have questions about which medicines contain acetaminophen. ALCOHOL WARNING: If you consume 3 or more alcoholic drinks every day, ask your doctor whether you should take Flextra DS or other pain relievers/fever reducers. Flextra DS may cause liver damage. Alcohol use combined with this medicine may increase your risk for liver damage.

Disclaimer

This drug information is for your information purposes only, it is not intended that this information covers all uses, directions, drug interactions, precautions, or adverse effects of your medication. This is only general information, and should not be relied on for any purpose. It should not be construed as containing specific instructions for any particular patient. We disclaim all responsibility for the accuracy and reliability of this information, and/or any consequences arising from the use of this information, including damage or adverse consequences to persons or property, however such damages or consequences arise. No warranty, either expressed or implied, is made in regards to this information.

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Data Suggests Taken Alone As Effective As When Taken In Combination With Ibuprofen - Large scale community-based study shows NSAID offers no additional benefit to muscle relaxant in treatment of acute pain and muscle spasm of the back or neck
More is not necessarily better when it comes to treating acute muscle pain and spasm of the back or neck, suggest results from the first community-based trial to evaluate the benefits of adding a non-steroidal anti inflammatory (NSAID) to treatment with a commonly prescribed muscle relaxant. According to the study, the muscle relaxant FLEXERIL 5 mg (cyclobenzaprine HCl), taken three times a day, is as effective alone as when taken in combination with ibuprofen at over-the-counter (OTC) or prescription doses.
More than 770 adult back and neck pain and muscle spasm sufferers at multiple community-based sites throughout the United States completed the randomized, multi-center, open-label one-week study, which compared thrice-daily treatment with FLEXERIL 5 mg alone or in combination with ibuprofen at over-the-counter (1,200 mg/day) or prescription doses (2,400 mg/day). Researchers shared results of the trial today at the 2004 Scientific Assembly of the American College of Emergency Physicians. A final report, including full data on all endpoints, will be completed soon.
"In clinical practice, acute muscle pain with spasm is often treated with an non-steroidal anti-inflammatory drug (NSAID) alone or in combination with a muscle relaxant," explained Martin Childers, D.O., Ph.D., associate professor, Department of Physical Medicine and Rehabilitation, School of Medicine, University of Missouri-Columbia. :The data from this study indicates that the addition of ibuprofen offers no further pain relief compared to taking FLEXERIL 5 mg alone."
About the Study
Men and women between 18 and 65 years of age with acute muscle pain with spasm of the neck or back of up to 14 days participated in the seven-day study conducted by more than 100 physicians. Patients self-reported pain intensity and muscle spasm intensity at baseline and after three and seven days of randomized treatment of FLEXERIL 5 mg three-times-a-day alone or in combination therapy with over-the-counter ibuprofen 400 mg three times a day (tid) or prescription dose ibuprofen 800 mg tid.
Results showed that all three treatments had statistically significant improvements for both spasm and pain from baseline after three and seven days of therapy. Additionally, the changes from baseline were significantly greater after one week of therapy than after three days for all three treatments for spasm and pain. This treatment duration finding was expected and consistent with previous studies. There were no statistically significant differences among the groups.
The types of adverse events observed in this study were consistent with the known safety profiles of these medications.

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